[Federal Register Volume 61, Number 135 (Friday, July 12, 1996)]
[Rules and Regulations]
[Page 36624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17686]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
Advisory Committees; Conversion of Ad Hoc Advisory Committee to
Standing Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
standing advisory committees' regulations to add the name and function
of the Transmissible Spongiform Encephalopathies Advisory Committee
(formerly Ad Hoc Advisory Committee on Creutzfeldt-Jakob Disease).
Appearing elsewhere in this issue of the Federal Register is a notice
announcing the renewal of this advisory committee. A notice requesting
nominations for membership on this committee will publish at a later
date. This action is being taken to incorporate this committee into the
agency's list of standing advisory committees because it will no longer
be serving in an ad hoc capacity.
EFFECTIVE DATE: July 12, 1996.
FOR FURTHER INFORMATION CONTACT: Donna M. Combs, Committee Management
Office (HFA-306), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-2765.
SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the Ad
Hoc Advisory Committee on Creutzfeldt-Jakob Disease has been changed.
The committee was established on June 21, 1995, to advise the
Commissioner of Food and Drugs regarding the safety of blood products
obtained or prepared from one or more donations from a donor who, after
donation, was diagnosed with Creutzfeldt-Jakob Disease. The committee
was chartered for the duration of 1 year.
The Commissioner has now formally determined that there is a
continuing need for this committee, that the name and function of the
committee will be changed to more accurately describe the committee,
and that the committee will no longer be serving in an ad hoc capacity.
The name ``Transmissible Spongiform Encephalopathies Advisory
Committee''will more accurately describe the subject area for which the
committee is responsible. The change is consistent with the expanded
function of the committee.
The committee's new function is to review and evaluate available
scientific data concerning the safety of products which may be at risk
for transmission of spongiform encephalopathies having an impact on the
public health as determined by the Commissioner of Food and Drugs. The
committee will also make recommendations to the Commissioner regarding
the regulation of such products.
Management and support services for the committee will continue to
be provided by FDA's Center For Biologics Evaluation and Research. In
this document, FDA is formally incorporating this committee into the
agency's list of standing advisory committees by adding a new paragraph
in 21 CFR 14.100(b).
Publication of this final rule constitutes a final action on this
change under the Administrative Procedure Act. Under 5 U.S.C.
553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the agency finds good
cause to dispense with notice and public procedure and to proceed to an
immediately effective regulation. Such notice and procedures are
unnecessary and are not in the public interest, because the final rule
is merely codifying the new name and expanded function of the advisory
committee, as well as its status as a standing advisory committee, and
when effective will reflect the current committee charter.
List of Subjects in 21 CFR Part 14
Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
14 is amended as follows:
PART 14-PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
1. The authority citation for 21 CFR part 14 continues to read as
follows:
Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321-394; 21 U.S.C. 41-50, 141-149, 467f, 679, 821,
1034; secs. 2, 351, 354, 361 of the Public Health Service Act (42
U.S.C. 201, 262, 263b, 264); secs. 2-12 of the Fair Packaging and
Labeling Act (15 U.S.C. 1451-1461); 5 U.S.C. App. 2; 28 U.S.C. 2112.
2. Section 14.100 is amended by adding new paragraph (b)(6) to read
as follows:
Sec. 14.100 List of standing advisory committees.
* * * * *
(b) * * *
(6) Transmissible Spongiform Encephalopathies Advisory Committee.
(i) Date established: June 21, 1995.
(ii) Function: Reviews and evaluates available scientific data
concerning the safety of products which may be at risk for transmission
of spongiform encephalopathies having an impact on the public health.
* * * * *
Dated: July 5, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-17686 Filed 7-11-96; 8:45 am]
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